Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001712-28 | EudraCT Number | ||
| U1111-1267-1489 | Other Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The research study will investigate the safety and tolerability of ZP8396 in healthy study participants. In addition, the study will investigate how ZP8396 works in the body (pharmacokinetics and pharmacodynamics).
Participants will receive 1 single dose either as an injection under the skin (subcutaneous, s.c.) or an injection into a vein of one arm (intravenous, i.v.).
Participants will have 9 visits with the study team. One of these visits consists of 8 overnight stays at the study site. For each participant, the study will last up to 66 days.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZP8396 | Experimental | Up to 10 single dose cohorts are planned with 8 subjects in each; 6 participants in each cohort will receive active treatment. |
|
| Placebo (ZP8396) | Placebo Comparator | In each of the 10 single dose cohorts, 2 subjects will receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZP8396 | Drug | Participants will receive 1 single dose of ZP8396 given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm). Dose level will depend on the cohort. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events (TEAEs) | From dosing (Day 1) to end of trial (Day 50) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of ZP8396 (AUCτ) | Area under the plasma concentration-time curve over a dosing interval | Day 1 (pre-dose) to Day 50 (1176 hours post-dose) |
| Pharmacokinetics (PK) of ZP8396 (AUCinf) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zealand Pharma A/S | Zealand Pharma A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH | Neuss | North Rhine-Westphalia | 41460 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
First human dose trial. A single-centre, placebo-controlled, double-blind (within cohorts), randomised single dose trial.
Not provided
Not provided
Not provided
| Placebo (ZP8396) | Drug | Participants will receive 1 single dose of placebo given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm). |
|
Area under the plasma concentration-time curve from time zero to infinity
| Day 1 (pre-dose) to Day 50 (1176 hours post-dose) |
| Pharmacokinetics (PK) of ZP8396 (AUClast) | Area under the plasma concentration-time curve from time zero to the time of the last measurable concentration | Day 1 (pre-dose) to Day 50 (1176 hours post-dose) |
| Pharmacokinetics (PK) of ZP8396 (Cmax) | Maximum (peak) plasma drug concentration | Day 1 (pre-dose) to Day 50 (1176 hours post-dose) |
| Pharmacokinetics (PK) of ZP8396 (tmax) | Time to reach maximum (peak) plasma concentration | Day 1 (pre-dose) to Day 50 (1176 hours post-dose) |
| Pharmacokinetics (PK) of ZP8396 (λz) | Elimination rate constant | Day 1 (pre-dose) to Day 50 (1176 hours post-dose) |
| Pharmacokinetics (PK) of ZP8396 (t½) | Elimination half-life | Day 1 (pre-dose) to Day 50 (1176 hours post-dose) |
| Pharmacokinetics (PK) of ZP8396 (Vz/f) | Apparent volume of distribution during terminal phase | Day 1 (pre-dose) to Day 50 (1176 hours post-dose) |
| Pharmacokinetics (PK) of ZP8396 (Vz) | Volume of distribution during the terminal phase (i.v. only) | Day 1 (pre-dose) to Day 50 (1176 hours post-dose) |
| Pharmacokinetics (PK) of ZP8396 (CL/f) | Apparent total clearance of the drug from plasma | Day 1 (pre-dose) to Day 50 (1176 hours post-dose) |
| Pharmacokinetics (PK) of ZP8396 (CL) | Total body clearance of the drug (i.v. only) | Day 1 (pre-dose) to Day 50 (1176 hours post-dose) |
| Pharmacokinetics (PK) of ZP8396 (MRT) | Mean residence time | Day 1 (pre-dose) to Day 50 (1176 hours post-dose) |
| Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax acetaminophen) | Maximum acetaminophen concentration after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen | 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5 |
| Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax acetaminophen) | Time to maximum acetaminophen concentration after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen | 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5 |
| Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCacetaminophen, 0-60 min) | Area under the acetaminophen concentration-time curve from 0 to 60 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen | 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5 |
| Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCacetaminophen, 0-240 min) | Area under the acetaminophen concentration-time curve from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen | 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5 |
| Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, Plasma Glucose [PG]) | Maximum PG concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen | 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5 |
| Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, Plasma Glucose [PG]) | Time to maximum PG concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen | 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5 |
| Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCPG,0-60 min) | Area under the Plasma Glucose (PG) concentration-time curve from 0 to 60 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen | 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5 |
| Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCPG,0-240 min) | Area under the Plasma Glucose (PG) concentration-time curve from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen | 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5 |
| Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, insulin) | Maximum insulin concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen | 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5 |
| Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, insulin) | Time to maximum insulin concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen | 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5 |
| Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCinsulin,0-60 min) | Area under the insulin concentration-time curve from 0 to 60 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen | 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5 |
| Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCinsulin,0-240 min) | Area under the insulin concentration-time curve from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen | 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5 |
| Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, glucagon) | Maximum glucagon concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen | 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5 |
| Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, glucagon) | Time to maximum glucagon concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen | 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5 |
| Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCglucagon,0-60 min) | Area under the glucagon concentration-time curve from 0 to 60 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen | 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5 |
| Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCglucagon,0-240 min) | Area under the glucagon concentration-time curve from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen | 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |